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National Institutes of Health approves Rapid Access to Interventional Development (NIH-RAID) for Edunn's EDN-OL1 drug


St. Louis, Mo (February 18, 2011) - Edunn has been notified that NIH-RAID (National Institute of Health - Rapid Access to Interventional Development) will carry out a project for preclinical development of EDN-OL1. The NIH-RAID Pilot Project web site has now listed the Edunn project for preclinical development of EDN-OL1.

The project approval followed from a proposal submitted by Dr. Darling in January, 2009, which was rated by a peer review panel of academic and Pharmaceutical company scientists between "Excellent and Outstanding." As a next step, NIH-RAID invited Edunn to present the proposal January 8th, 2010 for almost 3 hours. The Edunn group included Drs. W.A. Banks, Darling, Farr, and Lloyd, with reference to Drs. Morley and Kumar, and Board member Steve Trampe. Drs. N. G. Wehner and D. Kornbrust also presented on development of drugs for Alzheimer's and antisense pharmacology and safety. A project approval email was received in Octobr, 2010, and the web site listing in February, 2011.

EDN-OL1 is moving steadily through preclinical development, which will be completed in the RAID project. The project will utilize NIH resources to carry out the material requirements and testing required to enable EDN-OL1 to go into Clinical Phase 1 trial. The NIH plans to begin animal safety testing in 1st Quarter 2011.

The significance to investors is that these direct costs, often termed the biotech "valley of death", would be $2-3M if Edunn carried out the work alone. Instead, NIH will carry out the project with NIH resources. Most important, the science of EDN-OL1 has been positively reviewed by scientists and scientific managers of the RAID program, an independent peer review panel comprised of senior academic and business scientists external to NIH, and also by managers of the National Institute of Aging which holds the primary Alzheimer's portfolio, the National Institutes of Neurological Disease and Stroke, and the National Institute of Mental Health. Edunn believes that this level of expert evaluation provides considerable validation of the science and strategy behind EDN-OL1, and greater expert scrutiny than most investors could themselves bring to evaluation of a biotech opportunity. The NIH project does not provide funds directly to Edunn, but rather non-dilutive support. The RAID preclinical program will manufacture Pharmaceutical grade EDN-OL1 and develop the animal safety and toxicology data required to enable submission of the IND and to begin human clinical trials. The IND is the Investigational New Drug document submitted to FDA for review after which Edunn can begin clinical Phase 1 safety testing of EDN-OL1 in patients.

EDN-OL1 is well into the preclinical development phase. The drug has moved beyond the activities most likely to fail in the "Discovery" phase and is well past those unpredictable costs. In biotechnology, the preclinical development phase is termed the "Valley of Death" for the risks posed especially by new drugs of for whose chemistry there is no previous history. The title "Valley of Death" most of all indicates the difficulty of funding preclinical development, which for EDN-OL1 will be completed by NIH-RAID.

We think it is important to state clearly that Edunn's antisense technology decreases biosynthesis of amyloid precursor protein (APP), but efficacy of EDN-OL1 does not require that Alzheimer's have an over expression of APP. Over production of APP in Late Onset Alzheimer's disease (LOAD), which is the most common form, is not supported by the most recently published human data, whereas oxidative damage, and most significantly the defective efflux of amyloid proteins from the AD brain into the cerebrospinal fluid are increasingly viewed as major problems. EDN-OL1m, mouse specific sequence, treatment stops oxidative damage, restores normal efflux, and cognitive function in mouse models of AD. Chemically similar phosphorothioate oligonucleotide drugs have demonstrated predictable and well documented safety in oncology trials of over 5,000 patients.